62684 Federal Register / Vol. 75, No. 197 / Wednesday, October 13, 2010 / Rules and Regulations 

§ 416.1002 Definitions. 

* * * * * 

Compassionate allowance means a 

determination or decision we make 

under a process that identifies for 

expedited handling claims that involve 

impairments that invariably qualify 

under the Listing of Impairments in 

appendix 1 to subpart P of part 404 of 

this chapter based on minimal, but 

sufficient, objective medical evidence. 

* * * * * 

■ 19. Amend § 416.1015 by revising the 

introductory text of paragraph (c), 

removing the word ‘‘or’’ at the end of 

paragraph (c)(2), redesignating 

paragraph (c)(3) as paragraph (c)(4), and 

adding a new paragraph (c)(3) to read as 

follows: 

§ 416.1015 Making disability 

determinations. 

* * * * * 

(c) Disability determinations will be 

made by: 

* * * * * 

(3) A State agency disability examiner 

alone if you are not a child (a person 

who has not attained age 18), and the 

claim is adjudicated under the quick 

disability determination process (see 

§ 416.1019) or as a compassionate 

allowance (see § 416.1002), and the 

initial or reconsidered determination is 

fully favorable to you. This paragraph 

will no longer be effective on November 

12, 2013 unless we terminate it earlier 

or extend it beyond that date by 

publication of a final rule in the Federal 

Register; or 

* * * * * 

■ 20. Amend § 416.1019 by revising 

paragraphs (b) introductory text, (b)(1), 

(b)(2), and (c) to read as follows: 

§ 416.1019 Quick disability determination 

process. 

* * * * * 

(b) If we refer a claim to the State 

agency for a quick disability 

determination, a designated quick 

disability determination examiner must 

do all of the following: 

(1) Subject to the provisions in 

paragraph (c) of this section, make the 

disability determination after consulting 

with a State agency medical or 

psychological consultant if the State 

agency disability examiner determines 

consultation is appropriate or if 

consultation is required under 

§ 416.926(c). The State agency may 

certify the disability determination 

forms to us without the signature of the 

medical or psychological consultant. 

(2) Make the quick disability 

determination based only on the 

medical and nonmedical evidence in 

the file. 

* * * * * 

(c) If the quick disability 

determination examiner cannot make a 

determination that is fully favorable, or 

if there is an unresolved disagreement 

between the disability examiner and the 

medical or psychological consultant 

(except when a disability examiner 

makes the determination alone under 

§ 416.1015(c)(3)), the State agency will 

adjudicate the claim using the regularly 

applicable procedures in this subpart. 

[FR Doc. 2010–25502 Filed 10–12–10; 8:45 am] 

BILLING CODE 4191–02–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Office of the Secretary 

45 CFR Part 162 

[CMS–0009–N] 

RIN 0938–AM50 

Health Insurance Reform; 

Announcement of Maintenance 

Changes to Electronic Data 

Transaction Standards Adopted Under 

the Health Insurance Portability and 

Accountability Act of 1996 

AGENCY: Office of the Secretary, HHS. 

ACTION: Notification. 

SUMMARY: This document announces 

maintenance changes to some of the 

Health Insurance Portability and 

Accountability Act of 1996 standards 

made by the Designated Standard 

Maintenance Organizations. The 

maintenance changes are nonsubstantive changes to correct minor 

errors, such as typographical errors, or 

to provide clarifications of the standards 

adopted in our regulations entitled 

‘‘Health Insurance Reform; 

Modifications to the Health Insurance 

Portability and Accountability Act 

(HIPAA) Electronic Transaction 

Standards,’’ published in the Federal 

Register on January 16, 2009. This 

document also instructs interested 

persons on how to obtain the 

corrections. 

FOR FURTHER INFORMATION CONTACT: 

Denise Buenning, (410) 786–6711 

Gladys Wheeler, (410) 786–0273 

SUPPLEMENTARY INFORMATION: 

I. Background 

The Health Insurance Portability and 

Accountability Act of 1996 (HIPAA) 

mandated the adoption of standards for 

electronically conducting certain health 

care administrative transactions 

between certain entities. Through 

subtitle F of title II of HIPAA, the 

Congress added to title XI of the Social 

Security Act (the Act) a new Part C, 

entitled ‘‘Administrative 

Simplification.’’ Part C of title XI of the 

Act consists of sections 1171 through 

1180. These sections define various 

terms and impose several requirements 

on the Department of Health & Human 

Services (HHS), health plans, health 

care clearinghouses, and certain health 

care providers concerning the electronic 

transmission of health information. 

On August 17, 2000, we published a 

final rule in the Federal Register (65 FR 

50312) entitled ‘‘Health Insurance 

Reform: Standards for Electronic 

Transactions’’ (hereinafter referred to as 

the Transactions and Code Sets rule). 

That rule implemented some of the 

HIPAA Administrative Simplification 

requirements by adopting standards 

developed by standard setting 

organizations (SSOs) for eight electronic 

transactions, and code sets to be used in 

those transactions. The SSOs are 

organizations that are accredited by the 

American National Standards Institute 

(ANSI), and that develop industry 

standards for, among others, the HIPAA 

transactions. We adopted standards 

developed by the Accredited Standards 

Committee X12 (hereinafter referred to 

as ASC X12) and the National Council 

for Prescription Drug Programs 

(NCPDP). We defined those transactions 

and specified the adopted standards at 

45 CFR part 162, subparts I and K 

through R. Designated Standard 

Maintenance Organizations (DSMOs) 

receive, manage, and process requested 

changes to the adopted standards in 

accordance with the process identified 

in the HIPAA regulations at § 162.900. 

A description of the DSMO process can 

be found in the May 31, 2002 proposed 

rule (67 FR 38050). Both ASC X12 and 

NCPDP are DSMOs. 

On August 22, 2008, we published a 

proposed rule in the Federal Register 

(73 FR 49742) entitled ‘‘Health 

Insurance Reform: Modifications to 

Electronic Data Transactions Standards 

and Code Sets’’ (hereinafter referred to 

as the Modifications proposed rule) 

proposing to modify the HIPAA 

transaction standards by adopting 

updated versions of the standards. On 

January 16, 2009, we published a final 

rule in the Federal Register (74 FR 

3296) entitled Health Insurance Reform; 

Modifications to the Health Insurance 

Portability and Accountability Act 

(HIPAA) Electronic Transaction 

Standards (hereinafter referred to as the 

Modifications final rule), that adopted 

updated versions of the standards for 


jdjones on DSK8KYBLC1PROD with RULES
Federal Register / Vol. 75, No. 197 / Wednesday, October 13, 2010 / Rules and Regulations 62685 

the electronic transactions originally 

adopted under HIPAA. We refer readers 

to the regulations cited above for a 

detailed discussion of the standards for 

electronic transactions and information 

about electronic data interchange, the 

statutory background, and the regulatory 

history. 

In the Transactions and Code Sets 

rule, we defined the terms 

‘‘modification’’ and ‘‘maintenance of 

standards.’’ We explained that, when a 

change is substantial enough to justify 

publication of a new version of an 

implementation specification, such 

change is considered a modification, 

and must be adopted by the Secretary 

through regulation (65 FR 50322). 

Maintenance, on the other hand, 

describes the activities necessary to 

support the use of a standard, including 

technical corrections to an 

implementation specification. 

Maintenance changes are typically 

changes that are obvious to readers of 

the implementation guides, are not 

controversial, and are essential to 

implementation (68 FR 8388, (February 

20, 2003)). We note that regulatory 

action is not required to make 

maintenance type changes to the HIPAA 

adopted standards (65 FR 50322). 

II. Provisions of the Notification 

A. ASC X12 Version 5010 HIPAA 

Transaction Standards 

We adopted ASC X12 standards for 

the following eight HIPAA 

administrative transactions: (1) Health 

care claims or equivalent encounter 

information; (2) health care payment 

and remittance advice; (3) coordination 

of benefits; (4) eligibility for a health 

plan; (5) health care claim status; 

(6) enrollment and disenrollment in a 

health plan; (7) referral certification and 

authorization; and (8) health plan 

premium payments. In the January 16, 

2009 Modifications final rule, we 

adopted the ASC X12 Technical Reports 

Type 3, Version 005010 (hereinafter 

referred to as Version 5010) to replace 

the currently adopted Version 4010/ 

4010A1 standard for the eight HIPAA 

transactions (74 FR 3296). 

1. Errata Notification 

Following publication of the 

Modifications final rule, ASC X12 

notified HHS that they were receiving 

feedback from the industry regarding 

errors that had been overlooked during 

ASC X12 standards review process. 

These errors were not identified in the 

comments submitted during the public 

comment period for the Modifications 

proposed rule, and therefore are not 

reflected in the Version 5010 standards 

adopted in the Modifications final rule. 

After the industry reported these 

errors, ASC X12 compiled a summary 

and in February 2010 as required under 

the DSMO process, initiated 

consultations with HHS and the 

National Committee on Vital and Health 

Statistics (NCVHS), an advisory body to 

HHS on health data, statistics and 

national health information policy. (For 

a complete discussion of this NCVHS 

process, we refer readers to the August 

22, 2008 proposed rule (73 FR 49742). 

ASC X12 then balloted and completed 

approval for these changes to the 

Version 5010 standards in accordance 

with the established ASC X12 approval 

process, in July 2010. 

2. Errata Classification 

ASC X12 issued errata to Version 

5010 in July 2010. It has categorized the 

errata as both Type 1 and Type 2. These 

errata constitute maintenance changes 

under the HIPAA regulations, not 

modifications. The ASC X12 defines 

errata as: (1) Publication variances from 

approved X12 Committee actions 

(publication errors); or (2) editorial 

corrections such as spelling, 

punctuation, spelling out abbreviations 

or acronyms. 

ASC X12 further defines Type 1 and 

Type 2 errata as follows: 

• Type 1 Errata change the 

constraints of the base standard, but do 

not change the base standard itself. The 

sender and receiver must implement the 

Type I Errata in order to conduct a 

successful interchange. 

• Type 2 Errata supplement a 

published Technical Report Type 3 

(TR3) with minor changes that clarify or 

correct the TR3 Report. Implementation 

Guide constraints are not changed, and 

the sender and the receiver do not have 

to implement the errata to conduct a 

successful interchange. 

Neither Type 1 or Type 2 Errata can 

change the underlying base ASC X12 

transaction standard or associated 

internal code sets (http://www.x12.org/ 

newsletters/tr/index.cfm). 

3. Errata Distribution 

The errors that were identified by the 

industry, and ASC X12’s balloted and 

approved response that was completed 

July 2010, are contained in the errata 

posted to the ASC X12 Web site, at 

http://www.x12.org, and are available 

free of charge for purchasers of Version 

5010. In the interest of broad 

stakeholder outreach, CMS also posted 

a link for the ASC X12 errata to its Web 

site, at http://cms.gov/ICD10. 

B. NCPDP Telecommunication Standard 

D.0 

We adopted NCPDP standards for the 

following retail pharmacy drug 

transactions: Health care claims or 

equivalent encounter information; 

eligibility for a health plan; referral 

certification and authorization, 

coordination of benefits; and Medicaid 

pharmacy subrogation. In the 

Modifications final rule, we adopted the 

NCPDP Telecommunications Standard 

Implementation Guide, Version D, 

Release 0 (Version D.0) and equivalent 

NCPDP Batch Standard Implementation 

Guide, Version 1, Release 2 (Version 

1.2) in place of the NCPDP 

Telecommunication Standard 

Implementation Guide, Version 5, 

Release 1 (Version 5.1) and equivalent 

NCPDP Batch Standard Implementation 

Guide, Version 1, Release 1 (Version 

1.1), for the HIPAA retail pharmacy 

drug transactions. 

1. Change Notification 

Following publication of the 

Modifications final rule, NCPDP and 

industry stakeholders notified HHS that 

corrections were needed for errors in 

Version D.0 that had been either 

unintended mistakes or overlooked 

during the NCPDP standards review 

process. Those errors were not 

identified in the comments submitted 

during the public comment period for 

the Modifications proposed rule, and 

therefore are not reflected in the 

standards adopted in the Modifications 

final rule. 

After the industry reported these 

errors, NCPDP compiled a summary of 

the needed corrections and their 

proposed remedies, and in April 2010 

initiated consultations with HHS and 

the NCVHS. NCPDP balloted the 

changes and approved them, in 

accordance with the established NCPDP 

approval process, in August 2010. Each 

of the error corrections to Version D.0 

are maintenance changes, as that term is 

defined under the HIPAA regulations. 

2. NCPDP Change Distribution 

The errors that were identified by the 

industry, and NCPDP’s balloted and 

approved response that was completed 

in August 2010, are contained in the 

August 2010 publication of NCPDP 

Editorial Document posted to the 

NCPDP Web site, at http:// 

www.ncpdp.org. The publication of the 

changes is available free of charge for 

purchasers of Version D.0. In the 

interest of broad stakeholder outreach, 

CMS also posted a link for the NCPDP 

August 2010 Editorial Document to its 

Web site, at http://cms.gov/ICD10. 


jdjones on DSK8KYBLC1PROD with RULES
62686 Federal Register / Vol. 75, No. 197 / Wednesday, October 13, 2010 / Rules and Regulations 

It is important that HIPAA covered 

entities, vendors, and third party billers 

obtain the ASC X12 Version 5010 and 

the NCPDP Version D.0 error corrections 

and include them in their 

implementation of Version 5010 and 

Version D.0 standards. It should be 

noted that the HIPAA compliant 

versions include the error corrections. 

The Version 5010 and Version D.0 

HIPAA compliant standards should be 

incorporated into systems as soon as 

possible. There is urgency for entities to 

do so quickly in light of the HHSspecified Version 5010 and Version D.0 

January 1, 2011 testing date and the 

January 2012 implementation date. In 

addition, adhering to these time frames 

is critical for meeting the requirements 

to implement Version 5010 and Version 

D.0 prior to the October 2013 

implementation date for the ICD–10 

code set. 

The ASC X12 Standards for Electronic 

Data Interchange Technical Report Type 

3 and Errata may be obtained from the 

ASC X12, 7600 Leesburg Pike, Suite 

430, Falls Church, VA 22043; Telephone 

(703) 970–4480; Fax: (703) 970 4488. 

They also are available through the 

Internet at http://www.X12.org. 

The implementation specifications 

and the NCPDP D.0 Editorial Document 

may be obtained from the National 

Council for Prescription Drug programs, 

9240 East Raintree Drive, Scottsdale, AZ 

85260; Telephone (480) 477–1000; Fax: 

(480) 767–1042. They are also available 

through the Internet at http:// 

www.ncpdp.org. 

III. Collection of Information 

Requirements 

This document does not impose 

information collection and 

recordkeeping requirements. 

Consequently, it need not be reviewed 

by the Office of Management and 

Budget under the authority of the 

Paperwork Reduction Act of 1995. 

(Catalog of Federal Domestic Assistance 

Program No. 93.778, Medical Assistance 

Program; No. 93.773 Medicare—Hospital 

Insurance Program; and No. 93.774, 

Medicare—Supplementary Medical 

Insurance Program) 

Approved: October 6, 2010. 

Kathleen Sebelius, 

Secretary. 

[FR Doc. 2010–25684 Filed 10–8–10; 11:15 am] 

BILLING CODE 4150–29–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Office of the Secretary 

45 CFR Part 170 

RIN 0991–AB76 

Health Information Technology: 

Revisions to Initial Set of Standards, 

Implementation Specifications, and 

Certification Criteria for Electronic 

Health Record Technology 

AGENCY: Office of the National 

Coordinator for Health Information 

Technology (ONC), Department of 

Health and Human Services. 

ACTION: Interim final rule with request 

for comments. 

SUMMARY: The Department of Health and 

Human Services (HHS) is issuing this 

interim final rule with a request for 

comment to remove the implementation 

specifications related to public health 

surveillance. 

DATES: Effective Date: This interim final 

rule is effective October 13, 2010. 

Comment Date: To be assured 

consideration, written or electronic 

comments must be received at one of 

the addresses provided below, no later 

than 5 p.m. on November 12, 2010. 

ADDRESSES: Because of staff and 

resource limitations, we cannot accept 

comments by facsimile (FAX) 

transmission. You may submit 

comments, identified by RIN 0991– 

AB76, by any of the following methods 

(please do not submit duplicate 

comments). 

• Federal eRulemaking Portal: Follow 

the instructions for submitting 

comments. Attachments should be in 

Microsoft Word, WordPerfect, or Excel; 

however, we prefer Microsoft Word. 

http://www.regulations.gov. 

• Regular, Express, or Overnight Mail: 

Department of Health and Human 

Services, Office of the National 

Coordinator for Health Information 

Technology, Attention: Steven Posnack, 

Hubert H. Humphrey Building, Suite 

729D, 200 Independence Ave., SW., 

Washington, DC 20201. Please submit 

one original and two copies. 

• Hand Delivery or Courier: Office of 

the National Coordinator for Health 

Information Technology, Attention: 

Steven Posnack, Hubert H. Humphrey 

Building, Suite 729D, 200 Independence 

Ave., SW., Washington, DC 20201. 

Please submit one original and two 

copies. (Because access to the interior of 

the Hubert H. Humphrey Building is not 

readily available to persons without 

federal government identification, 

commenters are encouraged to leave 

their comments in the mail drop slots 

located in the main lobby of the 

building.) 

Inspection of Public Comments: All 

comments received before the close of 

the comment period will be available for 

public inspection, including any 

personally identifiable or confidential 

business information that is included in 

a comment. Please do not include 

anything in your comment submission 

that you do not wish to share with the 

general public. Such information 

includes, but is not limited to: A 

person’s social security number; date of 

birth; driver’s license number; state 

identification number or foreign country 

equivalent; passport number; financial 

account number; credit or debit card 

number; any personal health 

information; or any business 

information that could be considered to 

be proprietary. We will post all 

comments received before the close of 

the comment period at http:// 

www.regulations.gov. 

Docket: For access to the docket to 

read background documents or 

comments received, go to http:// 

www.regulations.gov or U.S. Department 

of Health and Human Services, Office of 

the National Coordinator for Health 

Information Technology, Hubert H. 

Humphrey Building, Suite 729D, 200 

Independence Ave., SW., Washington, 

DC 20201 (call ahead to the contact 

listed below to arrange for inspection). 

FOR FURTHER INFORMATION CONTACT: 

Steven Posnack, Director, Federal Policy 

Division, Office of Policy and Planning, 

Office of the National Coordinator for 

Health Information Technology, 202– 

690–7151. 

SUPPLEMENTARY INFORMATION: 

Acronyms 

ARRA American Recovery and 

Reinvestment Act of 2009 

CDC Centers for Disease Control and 

Prevention 

CFR Code of Federal Regulations 

EHR Electronic Health Record 

HHS Department of Health and Human 

Services 

HIT Health Information Technology 

HITECH Health Information Technology for 

Economic and Clinical Health 

HL7 Health Level Seven 

NAICS North American Industry 

Classification System 

OMB Office of Management and Budget 

ONC Office of the National Coordinator for 

Health Information Technology 

ONC–ATCB ONC-Authorized Testing and 

Certification Body 

PHSA Public Health Service Act 

RFA Regulatory Flexibility Act 

RIA Regulatory Impact Analysis 

UMRA Unfunded Mandates Reform Act of 

1995 


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